CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

K201207 · Fresenius Medical Care Renal Therapies Group, LLC · KOC · Sep 18, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201207
• Device Name: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware. The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation

Device Story

Extracorporeal hemodialysis blood tubing set; transports arterial blood from patient access through hemodialyzer and back to venous access. Includes integrated Crit-Line optical cuvette (blood chamber) for use with Crit-Line sensor clip. Used in acute/chronic hemodialysis clinics; operated by trained healthcare professionals. Provides clear viewing surface for sensor clip to transmit light through blood; enables non-invasive measurement of hematocrit, blood volume change, and oxygen saturation. Output used by clinicians to monitor patient status during dialysis; facilitates clinical decision-making regarding fluid management and therapy adjustments.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing, including structural integrity, pump segment performance, needle access port testing, connector leakage, tensile strength, spike performance, and functional testing of the Crit-Line chamber against control chambers. Biocompatibility testing per ISO 10993-1 and human factors validation were also conducted.

Technological Characteristics

Single-use, EO-sterilized PVC/PC/PP/PE/ABS/Polyisoprene tubing set. Includes integrated optical cuvette for Crit-Line sensing. Max flow 600 mL/min; max pressures -300/+500 mmHg. Connectors include DIN and Luer types. Non-electrical, non-software device.

Indications for Use

Indicated for acute and chronic hemodialysis therapy in patients requiring hemodialysis, using prescribed hemodialyzers and compatible Fresenius 2008 Series K, K2, or T machines.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• CAREline Hemodialysis Blood Tubing Sets (K172238)
• Crit-Line Clip (CLiC) Blood Chamber (K152953)

Reference Devices

• Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (K120823)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 18, 2020

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451

Re: K201207

Trade/Device Name: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC, FJK Dated: August 18, 2020 Received: August 19, 2020

Dear Denise Oppermann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal. Gastrointestinal. Obesity and Transplant Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K201207

# Device Name

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology and CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

# Indications for Use (Describe)

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware.

The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward pointing arrows stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".

# 5. 510(K) SUMMARY

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

# 5.1. Submitter's Information

| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|-------------------|-------------------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA<br>02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann, Senior Director<br>Regulatory Affairs – Devices |
| Preparation Date: | 28 January 2020 |

# 5.2. Device Name

| Trade Name: | CombiSet SMARTECH Hemodialysis Blood Tubing Sets |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Tubing Set |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | KOC/FJK |
| Product Code Name: | KOC – Accessories, Blood Circuit, Hemodialysis<br>FJK - Set, Tubing, Blood, With and Without Anti-regurgitation<br>Valve |
| FDA Review Panel: | Gastroenterology/Urology |

# 5.3. Legally Marketed Predicate Device

The legally marketed primary predicate device is the CAREline Hemodialysis Blood Tubing Sets cleared under K172238. The legally marketed secondary predicate device is the Crit-Line Clip (CLiC) Blood Chamber cleared under K152953. These devices have not been subject to a designrelated recall.

The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (K120823) is being used as a reference device.

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

# Device Description 5.4.

# 5.4.1. Device Identification:

The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:

- CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
- . CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")

# 5.4.2. Device Characteristics

The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.

## 5.4.3. Environment of Use

The CombiSet SMARTECH Bloodlines are used in environments where acute and chronic hemodialysis are performed.

# 5.4.4. Brief Written Description of the Device

The CombiSet SMARTECH Bloodlines are part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.

## 5.4.5. Materials of Use

The CombiSet SMARTECH Bloodlines are classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) devices in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (16 June 2016).

The materials used for each component of the CombiSet SMARTECH Bloodlines are listed in Table 1.

| Component | Material |
|-----------------------|-----------------------------------------------|
| Tubing and Components | Polyvinylchloride (PVC)<br>Polycarbonate (PC) |

## Table 1: Materials of Composition

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K201207

| Component | Material |
|---------------------------------------|-------------------------------------------------|
| | Polypropylene (PP) |
| | Polyethylene (PE) |
| | Acrylonitrile Butadiene Styrene (ABS) |
| | Polyisoprene |
| Transducer Protector | Polyester Polybutylene Terephthalate (PBT) |
| | Polytetrafluoroethylene (PFTE) |
| | PC |
| Integrated Crit-Line Blood<br>Chamber | PVC |
| | PE |
| | PC |
| Bonding Solvents | Cyclohexanone |
| | 50% Methyl Ethyl Ketone (MEK)/50% Cyclohexanone |
| | TetraMEK (95% Tetrahydrofuran/5% MEK) |

# Table 1: Materials of Composition

#### 5.4.6. Key Performance Specifications/Characteristics

The key performance specifications of the CombiSet SMARTECH Bloodlines are outlined in Table 2.

## Table 2: Key Performance Specifications

| Feature | Specification |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum Blood Flow Rate | 600 mL/min |
| Maximum Arterial Pressure | -300 mmHg |
| Maximum Venous Pressure | +500 mmHg |
| Pump Segment [Inner/Outer Diameter (ID/OD)] | 8.0 mm/12.0 mm |
| Functional CLiC Chamber Test - Hematocrit<br>(HCT) | The measured HCT using the CombiSet<br>SMARTECH Bloodline has a standard<br>deviation X2 of ≤ 3%, and an average bias of<br>≤ 1% (of the average HCT) as measured on<br>control blood chambers |
| Functional CLiC Chamber Test - Oxygen<br>Saturation (O2 Sat) | The measured O2 Sat using the CombiSet<br>SMARTECH Bloodline has a standard<br>deviation X2 of ≤ 3%, and an average bias of<br>≤ 2% (of the average O2 Sat) as measured on<br>control blood chambers |

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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

# 5.5. Intended Use

The CombiSet SMARTECH Bloodlines are intended for use in acute and chronic hemodialysis therapy.

# 5.6. Indications for Use

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K. K-and T Hemodialysis Machines equipped with Crit-Line hardware.

The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.

# 5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the CombiSet SMARTECH Bloodlines are substantially equivalent to those of the primary predicate CAREline Bloodlines (K172237) and secondary predicate CLiC Blood Chamber (K152953):

- Indications for Use
- Technological Characteristics
- . Design
- Performance Requirements

# 5.8. Sterilization Testing

The CombiSet SMARTECH Bloodlines are sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 106. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.

# 5.8.1. EO Residual Testing

Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Acceptable results (i.e., < 4.6 mg/device for EO and ECh) were obtained for the subject bloodlines.

# 5.8.2. Bacterial Endotoxin (Pyrogenicity) Testing

The subject bloodlines were tested for bacterial endotoxin (pyrogenicity) with Limulus Amebocyte Lysate (LAL) and determined to be non-pyrogenic (< 20 EU/device) in accordance with

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Image /page/7/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

ANSI/AAMI/ST72:2011/(R)2016 Bacterial Endotoxins – Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

## Sterile Barrier Testing 5.8.3.

Sterility of the blood pathway is maintained by the sterile fluid path of the device itself which includes the following components:

- Vented Caps
- Transducer Protectors (TPs) ●
- Tubing and all other components that make up the structural integrity of the bloodline's ● fluid path

The vented caps were qualified as part of the sterile barrier by microbial challenge tests in accordance with ANSI/AAMI/ISO 11607-1.

The TPs were qualified as part of the sterile barrier by a viral penetration test adapted from ASTM F1671-13.

The tubing and other components were qualified as part of the sterile barrier through the structural integrity test adapted from ISO 8638 and ASTM F2096-11. Testing was performed on samples after aging and distribution simulation.

# 5.9. Performance Data

Performance testing was conducted in accordance with ISO 8638:2010 and Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions (23 April 2008). Testing conducted to support the determination of substantial equivalence is summarized in Table 3.

| Test Conducted | Test Objective |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Structural Integrity | Demonstrate that the bloodlines can withstand 1.5X the labeled<br>maximum positive and negative pressures |
| Pump Segment<br>Performance | Evaluate performance characteristics of the bloodlines over the range of<br>the inlet pressures (normally 0 mmHg to -250 mmHg). Flow rate<br>settings will cover up to 600 mL/min. |
| Test Conducted | Test Objective |
| Visual Inspection for<br>Endurance and Simulated<br>Use Tests | Endurance<br>Demonstrate that bloodlines perform with no tubing failures (kinking,<br>collapsing, or disconnection) at the maximum labeled flow rate and<br>pressures for not less than 18 hr<br><br>Simulated Use<br>Demonstrate that bloodlines perform with no tubing failures (kinking,<br>collapsing, or disconnection) under simulated use conditions for not<br>less than 4 hr |
| Needle Access Port Test | Demonstrate that the needle access ports can withstand 1.5X the<br>labeled pressures after being punctured with the largest gauge needle<br>recommended in the labeling (21 gauge) – 6X for maximum positive<br>pressure, 11X for maximum negative pressure per ISO 8638:2010 |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to<br>fluid pressure of 300-330 kPa<br><br>ISO 80369-7:2016 specifies the test method, but it does not specify<br>requirements for hemodialyzer blood compartment port connectors.<br>However, the liquid leakage test from this standard has been adopted<br>using the reference connector from ISO 8638:2010 to test the DIN<br>connectors for this device. |
| Male and Female Luer<br>Connectors Tests | Demonstrate that the applicable components of the bloodlines meet the<br>dimensional and performance requirements of ISO 80369-7:2016<br>(Sections 5 and 6) |
| Visual Inspection for<br>Packaging (Shipping<br>study) | Demonstrate that shipping case, packaging configuration, and<br>palletization pattern maintain the product's structural integrity during<br>manual handling and motorized freight |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodlines between<br>components, and between components and tubing can withstand a<br>tensile force of 15 lbf |
| Spike Flow Rate | Demonstrate that the spike, a component of the bloodlines, can deliver<br>not less than 1000 mL of a sodium chloride solution in 10 min under a<br>static head of 1 m |
| Spike Insertion Force | Demonstrate that the spike, a component of the bloodlines, is capable<br>of piercing and penetrating the closure of an infusion device without<br>coring and with force not exceeding 200 N, when inserted at a rate of<br>500 mm/min |
| Test Conducted | Test Objective |
| Spike Leak Test | Demonstrate that the spike, a component of the bloodlines, will not leak<br>after piercing an infusion device, remaining pierced for 5 hr, and then<br>having an applied internal pressure of 20 kPa for 15 sec |
| Spike Disconnection<br>Force | Demonstrate that the spike, a component of the bloodlines, is capable<br>of being removed from the insertion point when a removal force is<br>applied at a rate of 100 mm/min. Establish the removal force value. |
| Labeling Content per<br>FDA Guidance (Blood<br>Tubing Set) and ISO<br>8638 | Verify the Instructions for Use, color coded components, unit labels,<br>shipping carton graphics, and case labels for the bloodlines meet the<br>requirements of ISO 8638:2010 and Guidance for Industry and FDA<br>Staff: Hemodialysis Blood Tubing Test – Premarket Notification<br>[510(k)] Submissions (April 2008) |
| Readability of Barcode<br>with Human Readable<br>Identification Codes | Demonstrate that the barcode information on the outer container labels<br>and unit labels for the bloodlines is capable of being scanned |
| Level Detector Test | Demonstrate that the venous chamber of the bloodline interfaces<br>correctly with the hemodialysis machine (2008 series) such that the<br>venous clamp will activate (close) when the fluid level inside the<br>venous chamber falls below the sensor heads |
| Air-Capture Chamber<br>Fill Level | Demonstrate that the recommended fill level of the air-capture<br>chambers is marked |
| Blood Filter Retention<br>Test | Demonstrate that the blood filter of the bloodlines remains in the<br>assembly position after tests at 1.5X the maximum recommended<br>positive pressure, with a flow rate of 600 mL/min for not less than<br>18 hr |
| Transparency of<br>Transducer Protectors | Demonstrate that the machine side of the transducer protectors (TPs) is<br>clear to allow for visual inspection of blood contamination during use |
| Transducer Protector<br>Leak Test | Demonstrate that the TP is capable of maintaining a secure and leak-<br>free connection to the hemodialysis machine |
| Viral Retentiveness Test<br>for Transducer Protectors | Demonstrate that the membrane inside the transducer protector<br>prevents can prevent the passage of bacteriophage (Φ Χ174) from the<br>patient side to the machine side up to a pressure of 600 mmHg for 1 hr |
| Torque Test (Connection<br>of Blood Chamber to<br>Dialyzer Connector) | Demonstrate that the bond connection between the Arterial DIN<br>connector and the CLiC Blood Chamber can withstand an applied<br>torque of not less than 14.8 in-lbs without creating a leak at 15 psi for<br>10 min |
| Test Conducted | Test Objective |
| Measure Gap between<br>Lenses | Demonstrate that the distance between the lenses from the CLIC Blood<br>Chamber is 0.078 ± 0.005 in |
| Functional CLIC<br>Chamber Test<br>(Hematocrit) | Demonstrate that the measurement of HCT of the integrated CLIC<br>Blood Chamber has a standard deviation X2 of ≤ 3%, and an average<br>bias of ≤ 1%, when compared to the HCT measurements made using a<br>production blood chamber (CL10041021) as control |
| Functional CLIC<br>Chamber Test (O2 Sat) | Demonstrate that the measurement of O2 Sat using the IBC blood<br>chamber will have a standard deviation X2 of ≤ 3%, and an average<br>bias of ≤ 2%, when compared to the O2 Sat measurements made using<br>a production blood chamber (CL10041021) as control |
| Tubing Compliance Test | Demonstrate that tubing is capable of being occlusively clamped by the<br>venous line clamp of the dialysis machine |
| Clamp Occlusion Test | Demonstrate that tubing is capable of being occlusively clamped by the<br>bloodline clamps |

Table 3: Performance Testing Summary

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# Table 3: Performance Testing Summary

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# Table 3: Performance Testing Summary

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Image /page/10/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

### Performance Testing Summary Table 3:

#### 5.9.1. Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (16 June 2016). The following testing was conducted to support the biological safety of the CombiSet SMARTECH Bloodlines:

- Cytotoxicity, Neutral Red Uptake
- Sensitization, Guinea Pig Maximization ●
- Intracutaneous Irritation ●
- Material-Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect)
- Hemocompatibility, Dynamic (Mechanical) Hemolysis
- Complement Activation, SC5b-9
- Platelet and Leukocyte Count
- Partial Thromboplastin Time (PTT)
- Semi-quantitative Leachable Chemical Evaluation, 20% Ethanol (Volatiles, Semi-. Volatiles, Non-Volatiles, Metals)
- Semi-quantitative Extractable Chemical Evaluation, Water, Hexane, 95% Ethanol ● (Volatiles, Semi-Volatiles, Non-Volatiles, Metals)

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K201207

#### 5.9.2. Human Factors Validation Testing

The CombiSet SMARTECH Bloodlines were validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

### 5.9.3. Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable. The CombiSet SMARTECH Bloodlines are not electrical mechanical devices.

#### 5.9.4. Software Verification and Validation Testing

Not applicable. The CombiSet SMARTECH Bloodlines do not contain software.

#### 5.9.5. Animal Studies

No animal studies were performed.

#### Clinical Studies 5.9.6.

No clinical studies were performed.

#### 5.10. Conclusion

The Indications for Use, technological characteristics, design, and performance requirements of the CombiSet SMARTECH Bloodlines are substantially equivalent to those of the predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the CombiSet SMARTECH Bloodlines are safe and effective for their intended use.

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.